Your browser does not support JavaScript! GOOD CARE STERILE SCRUB BRUSH WITH PCMX (CHLOROXYLENOL) SOLUTION [DALIAN GOODWOOD MEDICAL CARE LTD.]
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GOOD CARE STERILE SCRUB BRUSH WITH PCMX (chloroxylenol) solution
[Dalian Goodwood Medical Care Ltd.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Good Care Sterile Scrub Brush with 3.3% PCMX


Active Ingredient

3.3% Parachlorometaxylenol  Cleansing Solution With Emollient

Purpose

Antiseptic

Uses

  • For cleansing hands and arms prior to surgery

Warnings

  • For external use only
  • Do not use in eyes

Stop use and ask a doctor if

  •  skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control right away

Directions

  • Wet hands and forearms with water
  • Clean under nails with nail cleaner
  • Scrub for 3 minutes with the impregnated brush
  • Pay close attention to the nails, cuticles, and interdigital spaces
  • Rinse thoroughly with running water
  • Repeat

Other Information

  • Store at room temperature
  • Avoid excessive heat above 40 degrees C (104 degrees F)
  • Protect from freezing
  • Latex free

Inactive Ingredients

Citric Acid, PEG -120 Methyl Glucose Dioleate, Purified Water, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Sodium Lauryl Sulfate, Sodium Sulfonate, Soya Fatty Acid, Vinylpyrrolidone

Manufactured by Dalian Goodwood Medical Care Ltd.

Made in China

Good Care Sterile Scrub Brush with 3.3% PCMX (50685-008-00)


PCMX1

PCMX2

GOOD CARE STERILE SCRUB BRUSH WITH PCMX  
chloroxylenol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50685-008
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL3.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
PEG-120 METHYL GLUCOSE DIOLEATE 
WATER 
SODIUM HYDROXIDE 
SODIUM LAUROYL SARCOSINATE 
SODIUM LAURYL SULFATE 
SOYBEAN 
POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5)) 
Packaging
#Item CodePackage Description
1NDC:50685-008-0020 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E02/13/2013
Labeler - Dalian Goodwood Medical Care Ltd. (529575699)
Registrant - Dalian Goodwood Medical Care Ltd. (529575699)
Establishment
NameAddressID/FEIBusiness Operations
Dalian Goodwood Medical Care Ltd.529575699manufacture(50685-008)

Revised: 02/2013
Document Id: 424d19aa-9e50-42a7-8a79-0892060bf151
Set id: 037430e5-9b7d-45a7-bf27-aa22e26477b9
Version: 1
Effective Time: 20130227
 
Dalian Goodwood Medical Care Ltd.

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